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Genetic Labs

Houston, Texas

Genetic Laboratory
Medical Genetics Laboratories
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Medical Genetics Test Details

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PIK3CA Mutation Analysis - Tumor
Test Information: Indication for Study:

Identification of mutations in exons 9 and 20 of the PIK3CA gene.
Test Details
Test Code: 9035
Test Includes: Sequence Analysis of exons 9 & 20 of the PIK3CA gene.

Special Notes: This test can also be performed on Fresh Frozen Tissue (#9036).

Germline mutation analysis is required if novel mutations are detected. Please see detailed requirements under test code (#9037).

PIK3CA is commonly mutated and thereby activated in various human cancers, including colorectal cancer, malignant melanoma, thyroid carcinoma, non-small cell lung carcinoma, breast cancer, cervical cancer, and adenocarcinoma of lung. The most common mutations of PIK3CA are in exon 9 and exon 20. These mutations render tumor cells resistance to some anti-cancer therapies.

Technical Limitations:

This test is designed to detect mutations in exons 9 and 20 of the PIK3CA gene only. The limit of the test is approximately 20 mutated cells in 100 total cells (20%).

Results of this test must always be interpreted in the context of relevant clinical and pathological data, and should not be used alone for a diagnosis of malignancy.

Useful Publications:
- KRAS, BRAF, PIK3CA, and PTEN Mutations: Implications for Targeted Therapies in Metastatic Colorectal Cancer
- FGFR3, HRAS, KRAS, NRAS and PIK3CA Mutations in Bladder Cancer and Their Potential as Biomarkers for Surveillance and Therapy
Technical Information
Methodology: Sequence analysis is performed in both forward and reverse directions of exons 9 and 20 of the PIK3CA gene
Gene Name: PIK3CA
Protein Name: Phosphatidylinositol 3-Kinase, Catalytic, Alpha
Sample & Shipping Information
Test Requisition: Tumor Analysis
Specimen Type: FFPE - Slide(s)
Requirements: 5 unstained 5um FFPE slides containing adequate amounts of tumor to be analyzed with areas of tumor marked. Please include a copy of corresponding surgical pathology report.

Transport Temperature: sent at ambient temperature (18-25C/64-77F). Protect paraffin tissue from excessive heat. Ship in cooled container during summer months.

Unacceptable Conditions: No tumor in tissue. Frozen specimens and specimens fixed/processed in alternative fixatives.

Stability: Ambient: Indefinitely; Refrigerated: Acceptable.

Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Do not heat or freeze.


Specimen Type: FFPE - Tumor Block
Requirements: Paraffin-embedded, formalin-fixed tissue block containing adequate amounts of tumor to be analyzed with areas of tumor marked. Please include a copy of corresponding surgical pathology report.

Transport Temperature: sent at ambient temperature (18-25C/64-77F). Protect paraffin tissue from excessive heat. Ship in cooled container during summer months.

Unacceptable Conditions: No tumor in tissue. Frozen specimens and specimens fixed/processed in alternative fixatives.

Stability: Ambient: Indefinitely; Refrigerated: Acceptable.

Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Do not heat or freeze.

Turn Around Time: 14 days
Billing Information
List Price: *For Insurance or Institutional Prices, please call.
CPT Codes: 81479x1


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